- Wang M, et al. Acalabrutinib plus bendamustine and rituximab in untreated mantle cell lymphoma: results from the phase 3, double-blind, placebo-controlled ECHO trial. Abstract #LB3439, EHA congress 2024, 13–16 June, Madrid, Spain.
The phase 3 ECHO trial (NCT02972840) randomised 598 participants over 64 years of age with newly diagnosed MCL 1:1 to BR plus acalabrutinib or BR plus placebo. The primary endpoint was progression-free survival (PFS). “Participants in the placebo arm were permitted to cross over to acalabrutinib if they had disease progression,” noted Prof. Michael Wang (University of Texas, TX, USA)1.
After a median follow-up of 45 months, PFS was improved in the acalabrutinib arm compared with the placebo arm (HR 0.73; 95% CI 0.57–0.94; P=0.016). The median PFS was 66.4 months in the acalabrutinib and 49.6 months in the placebo arm. Of note, 69% of the participants in the placebo arm received BTK inhibitors as a subsequent treatment. According to Prof. Wang, there was a positive trend in OS as well, with a hazard ratio of 0.86 (95% CI 0.65–1.13; P=0.27). “If we censor for COVID-related deaths the OS trend was even more positive (HR 0.75; 95% CI 1.04; P=0.08),” emphasised Prof. Wang.
The safety profiles of the 2 treatment regimens did not differ substantially. Atrial fibrillation occurred in 6.1% of the participants on acalabrutinib and in 4.4% of placebo. Hypertension (12.1% vs 15.8%) and major bleeding (2.4% vs 5.4%) were slightly more common in the placebo arm, whereas infections (78.1% vs 71.0%) were more frequently reported in the acalabrutinib arm.
“The data from ECHO indicate that acalabrutinib plus BR may be a new first-line standard of care for older patients with MCL,” concluded Prof. Wang.
Medical writing support was provided by Robert van den Heuvel.